Actively Recruiting

Age: 18Years +
FEMALE
ID06294951

Functional Magnetic Resonance Imaging Findings and Symptoms in Bladder Pain Syndrome: A Descriptive Study

Led by RenJi Hospital · Updated on 2024-03-06

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how brain activity, shown through functional magnetic resonance imaging (fMRI), relates to symptoms in people with bladder pain syndrome (BPS). The study will explore where brain changes occur in these patients and seek clues to better understand the causes and possible treatments of BPS. It includes patients with and without urinary tract infections to compare findings. Participants will undergo one fMRI scan using a Siemens 3.0T MRI scanner with specific imaging sequences to capture brain function. Along with the fMRI, routine lab tests like urine analysis and ultrasound, and symptom questionnaires including pain scales and depression and anxiety assessments, will be completed. The study collects data during an initial screening visit and a follow-up visit after enrollment. During the study, participants will provide medical history, complete symptom and mood questionnaires, and undergo urine tests and bladder function assessments. Researchers will analyze fMRI brain images alongside symptom scores to identify brain regions linked to pain. The primary outcome is the fMRI findings from one scan per participant. Data management includes careful entry, verification, and long-term storage. Participation involves two visits and monitoring of symptoms and brain activity.

CONDITIONS

Brief Title

fMRI for BPS: A Descriptive Study of Findings and Symptoms

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Be 18 years of age or older and female
  • Diagnosed with bladder pain syndrome with persistent or recurrent bladder pain and related symptoms
  • Symptoms lasting more than 6 months
  • Pain score of 4 or higher on the Visual Analogue Scale (VAS)
  • O'Leary-Sant Interstitial Cystitis questionnaire (IC-Q) score of 12 or more with pain and nocturia scores above 2
  • Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF) score greater than 13
  • No cystoscopy performed within the past 2 years
Not Eligible

You will not qualify if you...

  • Previous bladder surgery or treatments for bladder pain syndrome
  • Pregnant or breastfeeding
  • Contraindications to MRI
  • Average urine output less than 40 ml or more than 400 ml
  • Blood in urine more than 1+ on dipstick test
  • Current urinary tract infection (for BPS group)
  • History of genitourinary tuberculosis or bladder/uroepithelial cancer
  • Recurrent urinary tract infections
  • History of hysterectomy, pelvic surgeries, or prostate procedures within 6 months
  • Neurological diseases such as stroke, multiple sclerosis, or Parkinson's disease
  • Reliance on catheterization
  • Planned bladder rehabilitation therapy affecting bladder function
  • For control group, evidence of current urinary tract infection required and some exclusion criteria adjusted accordingly

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

2 visits (in-person) including the day of signing informed consent and the day of completion of screening

Diagnostic Evaluation

Duration - 1 day

Participants undergo assessments including questionnaires, urine tests, ultrasound, urodynamics, and a one-time fMRI scan to evaluate bladder pain syndrome symptoms and brain function.

1 visit (in-person) for assessments and fMRI

Trial Site Locations

Total: 1 location

1

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200127

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Research Team

Z

Zhebin Du, Dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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